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MRL Review Progress Under Article 12 of Regulation (EC) No 396/2005

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MRL Review Progress Under Article 12 of Regulation (EC) No 396/2005 Last update: 20 July 2021 Overview of the MRL review progress under Article 12 of Regulation (EC) No 396/2005 The current document presents the status of the Maximum Residues Levels (MRL) reviews (ongoing and upcoming) under Article 12 of Regulation (EC) No 396/2005. In order to improve the communication with stakeholders, EFSA is publishing the detailed work programme (progress report) to allow stakeholders to better prepare and support the MRL review. The document will be updated on a quarterly basis and published on the EFSA website. This document focusses on the substances under the ‘new’ procedure agreed with Commission and Member States at the Pesticide Steering Network (PSN) meeting in June 2014 and modified at the Pesticide Steering Network meeting in November 2019 (see Art.12 MRL work instructions). All substances that were assessed under the ‘interim’ procedure have been finalised. With the new procedure EFSA starts the process by launching a call for data and coordinates the activities of the RMS, Member States (MSs) and the UK1 in collecting authorised good agricultural practices (GAPs) and residue trials. The Article 12 MRL review in parallel with renewal peer review (COMBINED assessment) procedure considers substances for which the Art.12 review has not been conducted and that are currently temporarily included in Annex IV or for which the Annex IV inclusion is pending. In order to optimise resources (for both EFSA and MSs), in agreement with EC and MSs (presented at September 2019 PAFF) EFSA is launching the GAP collection of all authorised uses in parallel to the peer review for the renewal. Once all GAPs have been collected, it can be evaluated if the data submitted to support the representative use(s) cover all authorised uses and import tolerances and thus the EFSA Conclusion could also address the Art.12 question number. This will avoid re-visiting the substance for the MRL review based on the same data package as assessed during the peer review. In case the GAP collection results in authorised GAPs that cannot be assessed based on the data submitted for renewal of a given active substance, the MRL review will not continue and will stay on hold until the renewal process is concluded. This proposal is therefore not creating unnecessary additional work for the RMS, as the only step is the GAP collection and there is no need to prepare an evaluation report. Finally, it is underlined that the work plan published as part of the June 2014 Pesticides Steering Network (PSN) minutes (Appendix B.2 and B.3 to the Minutes of the 1st meeting on the MRLs procedures) should be considered superseded by this document. When looking at the progress report, the following information should also be taken into account: Dates reported in the cells correspond to the starting and foreseen dates to complete the assessment. 1 For MRL reviews launched after 1/1/21 until 2025: ‘The United Kingdom withdrew from EU on 1 February 2020. In accordance with the Agreement on the Withdrawal of the United Kingdom from the EU, and in particular with the Protocol on IE/NI, the EU requirements on data reporting are also applicable to NI’. The report includes the active substances expected to be assessed under the new procedure or the combined. Completed reviews finalised under the former and the interim processes as well as finalised statements comprising of active substances that do not require a review of the existing MRLs under Art 12 of Regulation (EC) No 396/2005 are not included in this report; the finalised Reasoned Opinions for these old reviews as well as the statements can be retrieved from the EFSA website. Re-prioritisation of some substances is possible and will be decided in collaboration with DG SANTE and Member States taking into account on-going or upcoming assessments under other procedures (i.e. renewal, confirmatory data following the approval). EFSA may need to await the outcome of another assessment before proceeding with the MRL review for a certain active substance (renewal of the approval, confirmatory data for the approval). Therefore, for certain substances no starting date is indicated, and it is mentioned ‘to be defined’ in the below overview table. The publication of an output is expected generally within 4 weeks from its adoption. Details on the different steps of the process are available in the Art.12 MRL work instructions. 2 Active Substance RMS Process Start of data Adoption of the collection RO (expected date) 1. alpha-Cypermethrin BE New 16/04/2021 16/04/2022 2. Aluminium silicate (aka kaolin) EL COMBINED 05/03/2021 5/03/2022 3. Azadirachtin DE New to be defined to be defined 4. Bacillus thuringiensis subsp. Aizawai NL New*** to be defined to be defined (ABTS-1857 and GC-91) 5. Bacillus thuringiensis subsp. SE New*** to be defined to be defined Israelensis (serotype H-14), AM65-52 6. Bacillus thuringiensis subsp. Kurstaki DK New*** to be defined to be defined (ABTS 351, PB 54, SA 11, SA 12 and EG 2348) 7. beta-Cyfluthrin DE New 15/09/2020 27/10/2021 8. Beta-cypermethrin BE New 12/05/2021 16/04/2022 9. Chlorates (incl. Mg, Na, K chlorates) FR STATEMENT not applicable ** 10. Chlorsulfuron PL STATEMENT 13/07/2018 * 11. Clofentezine ES New to be defined to be defined 12. Clopyralid FI New to be defined to be defined 13. Cyflumetofen ES New 15/06/2020 31/07/2021 14. Cyfluthrin DE New 15/09/2020 27/10/2021 15. Cypermethrin BE New 15/04/2021 16/04/2022 16. Dicamba DK New to be defined to be defined 17. Didecyldimethylammonium chloride NL New to be defined to be defined (DDAC) 18. Difenoconazole ES New to be defined to be defined 19. Dimethoate IT STATEMENT not applicable ** 20. Dithianon EL New 15/03/2021 23/04/2022 21. Epoxiconazole PL STATEMENT not applicable ** 22. Ethoprophos IT STATEMENT not applicable ** 23. Ethylene NL COMBINED to be defined to be defined 24. Etridiazole NL STATEMENT 14/02/2018 * 25. Eugenol ES New to be defined to be defined 26. Extract from tea tree PL COMBINED to be defined to be defined 27. Fatty acids C7 to C20 EL New*** to be defined to be defined 28. Fenoxaprop-P AT New to be defined to be defined 29. Fosthiazate DE New to be defined to be defined 30. Gamma-cyhalothrin DE New to be defined to be defined 31. Geraniol ES New to be defined to be defined 32. Gibberellic acid SI New*** to be defined to be defined 33. Gibberellin SI New*** to be defined to be defined 34. Halosulfuron-methyl IT New to be defined to be defined 35. Hydrolysed proteins ES COMBINED 05/02/2021 21/01/2022 36. Iron sulphate HU COMBINED to be defined to be defined 37. Isoxaben SE New 16/10/2020 20/12/2021 38. Lenacil BE New to be defined to be defined 3 Active Substance RMS Process Start of data Adoption of the collection RO (expected date) 39. Malathion CZ New to be defined to be defined 40. Mancozeb EL New 15/12/2020 2/03/2022 41. Maneb IT New 15/12/2020 2/03/2022 42. MCPA PL New to be defined to be defined 43. MCPB PL New to be defined to be defined 44. Metarhizium anisopliae var. NL New*** to be defined to be defined Anisopliae (BIPESCO 5/F52) (formerly Metharhizium anisopliae) 45. Methiocarb (aka mercaptodimethur) DE STATEMENT not applicable ** 46. Metiram (aka carbatene, aka zineb IT New 16/11/2020 2/03/2022 ethylene thiuram disulphide adduct) 47. Metobromuron FR New 15/05/2020 29/09/2021 48. Metribuzin EE New to be defined to be defined 49. Nicotine FR New to be defined to be defined 50. Novaluron DE New 18/11/2019 12/01/2022 51. Penthiopyrad SE New 18/02/2020 31/07/2021 52. Phosmet ES New 15/09/2021 15/09/2022 53. Picloram PL New to be defined to be defined 54. Plant oils / Citronella oil FR COMBINED to be defined to be defined 55. Plant oils / Clove oil ES COMBINED to be defined to be defined 56. Plant oils / Rape seed oil NL COMBINED 30/09/2020 30/09/2021 57. Plant oils / Spear mint oil SE COMBINED to be defined to be defined 58. Pyrethrins IT New to be defined to be defined 59. Pyriproxyfen NL New 15/08/2021 15/08/2022 60. Pythium oligandrum (M1) SE New*** to be defined to be defined 61. Quartz sand LV COMBINED 31/05/2021 31/05/2022 62. Repellants: Fish Oil CZ COMBINED 27/11/2020 27/11/2021 63. Repellants: Sheep fat CZ COMBINED 27/11/2020 27/11/2021 64. Spirodiclofen AT New 18/08/2020 29/11/2021 65. Straight chain Lepidoptera IT New*** to be defined to be defined pheromones 66. Tetraconazole FR New 16/10/2020 6/12/2021 67. Thymol ES New to be defined to be defined 68. Topramezone FR STATEMENT not applicable ** 69. Tri-allate NL New to be defined to be defined 70. zeta-Cypermethrin AT New 12/05/2021 16/04/2022 71. Ziram IT New 16/11/2020 2/03/2022 72. Zoxamide LV New to be defined to be defined RMS: Rapporteur Member State; RO: Reasoned Opinion. * Following consideration of data submitted so far, in agreement with EC and RMS the Art.12 MRL Review is discontinued for this substance. The substance will be included in a statement. ** In agreement with EC, the Art.12 MRL review will be covered by a statement.
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